BACKGROUND: Cisplatin and fluoropyrimidine (CF) are standard first- line treatment in advanced gastric cancer, but no second-line treatment has yet been established. We present a phase II study in which we evaluated the efficacy and toxicity of the combination of Sorafenib (S), and Oxaliplatin as second-line therapy. METHODS: Patients with progressive gastric adenocarcinoma after CF- first-line, ECOG 0-2, and measurable disease were included. The primary objective was PFS. Treatment doses were Oxaliplatin 130 mg/m²/3 weeks and Sorafenib 800 mg/bid/d. RESULTS: We included 40 patients. CR was 2.5% and SD was 47.2%. Grade 3-4 toxic effects were neutropenia (9.8%), thrombocytopenia (7.3%), neurotoxicity (4.9%) and diarrhea (4.9%). Median PFS was 3 months (95%CI: 2.3-4.1) and median OS was 6.5 months (95% CI: 5.2-9.6). Time to progression (TTP) to first line therapy was a prognosis factor. Median OS was 9.7 months when time-to-progression during first-line chemotherapy was >6 months and 5.6 m when it was <6 months (p = 0.04). CONCLUSIONS: Time-to-progression under a CF-based first-line therapy determines subgroups of GC patients with different prognosis. The combination of Oxaliplatin-Sorafenib in advanced GC patients previously treated with CF appears safe, but our results do not support the implementation of a phase III trial.
BACKGROUND:Cisplatin and fluoropyrimidine (CF) are standard first- line treatment in advanced gastric cancer, but no second-line treatment has yet been established. We present a phase II study in which we evaluated the efficacy and toxicity of the combination of Sorafenib (S), and Oxaliplatin as second-line therapy. METHODS:Patients with progressive gastric adenocarcinoma after CF- first-line, ECOG 0-2, and measurable disease were included. The primary objective was PFS. Treatment doses were Oxaliplatin 130 mg/m²/3 weeks and Sorafenib 800 mg/bid/d. RESULTS: We included 40 patients. CR was 2.5% and SD was 47.2%. Grade 3-4 toxic effects were neutropenia (9.8%), thrombocytopenia (7.3%), neurotoxicity (4.9%) and diarrhea (4.9%). Median PFS was 3 months (95%CI: 2.3-4.1) and median OS was 6.5 months (95% CI: 5.2-9.6). Time to progression (TTP) to first line therapy was a prognosis factor. Median OS was 9.7 months when time-to-progression during first-line chemotherapy was >6 months and 5.6 m when it was <6 months (p = 0.04). CONCLUSIONS: Time-to-progression under a CF-based first-line therapy determines subgroups of GC patients with different prognosis. The combination of Oxaliplatin-Sorafenib in advanced GC patients previously treated with CF appears safe, but our results do not support the implementation of a phase III trial.
Authors: Peter C Thuss-Patience; Albrecht Kretzschmar; Dmitry Bichev; Tillman Deist; Axel Hinke; Kirstin Breithaupt; Yasemin Dogan; Bernhard Gebauer; Guido Schumacher; Peter Reichardt Journal: Eur J Cancer Date: 2011-10 Impact factor: 9.162
Authors: Bernard Escudier; Tim Eisen; Walter M Stadler; Cezary Szczylik; Stéphane Oudard; Michael Siebels; Sylvie Negrier; Christine Chevreau; Ewa Solska; Apurva A Desai; Frédéric Rolland; Tomasz Demkow; Thomas E Hutson; Martin Gore; Scott Freeman; Brian Schwartz; Minghua Shan; Ronit Simantov; Ronald M Bukowski Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245
Authors: Jung Hun Kang; Soon Il Lee; Do Hyoung Lim; Keon-Woo Park; Sung Yong Oh; Hyuk-Chan Kwon; In Gyu Hwang; Sang-Cheol Lee; Eunmi Nam; Dong Bok Shin; Jeeyun Lee; Joon Oh Park; Young Suk Park; Ho Yeong Lim; Won Ki Kang; Se Hoon Park Journal: J Clin Oncol Date: 2012-03-12 Impact factor: 44.544
Authors: David Cunningham; Naureen Starling; Sheela Rao; Timothy Iveson; Marianne Nicolson; Fareeda Coxon; Gary Middleton; Francis Daniel; Jacqueline Oates; Andrew Richard Norman Journal: N Engl J Med Date: 2008-01-03 Impact factor: 91.245
Authors: Jolien Tol; Miriam Koopman; Annemieke Cats; Cees J Rodenburg; Geert J M Creemers; Jolanda G Schrama; Frans L G Erdkamp; Allert H Vos; Cees J van Groeningen; Harm A M Sinnige; Dirk J Richel; Emile E Voest; Jeroen R Dijkstra; Marianne E Vink-Börger; Ninja F Antonini; Linda Mol; Johan H J M van Krieken; Otilia Dalesio; Cornelis J A Punt Journal: N Engl J Med Date: 2009-02-05 Impact factor: 91.245
Authors: Felice Pasini; Anna Paola Fraccon; Yasmina Modena; Maria Bencivenga; Simone Giacopuzzi; Francesca La Russa; Milena Gusella; Giovanni de Manzoni Journal: Gastric Cancer Date: 2016-08-27 Impact factor: 7.370